Getting Started With
eISF and Monitoring

A step-by-step guide to setting up your eISF and preparing for monitoring visits in SiteVault eReg.

Veeva SiteVault

SiteVault eReg is an electronic investigator site file (eISF) that provides remote access to regulatory and source documents. It is compliant with global industry regulations (including 21 CFR 11, Annex 11, and GDPR) and can be used across all studies.

Getting started with SiteVault is easy! Follow the steps below to set up your study. If you need help, please reach out to Veeva’s Site Support team at or via chat from the bottom right corner of the Help Center.

1. Add Your Staff

Add staff to SiteVault to reuse documents, send training materials, and use eSignature for all studies. If you are using SiteVault for monitoring at the request of your Sponsor/CRO, add staff that will collaborate on uploading documents for monitoring.

  1. Log in to SiteVault, your email is your username.
  2. Navigate to Administration > Staff and select Create.
  3. Enter the staff’s email address, then select Check Email.
  4. Complete the required fields and assign a system role. We recommend assigning the Site Administrator role to team members who work across all studies and manage documents. For all other staff, assign the Site Staff role.
  5. Click Save. Staff will receive a welcome email with a link to log in and set their password.

Need Help? Contact support at

Adding Your Staff to SiteVault

2. Create a Study and Assign Your Team

Create your study in SiteVault to assign your study team and begin uploading documents:

  1. Navigate to the Studies tab.
  2. Click Create.
  3. Enter the study name and any additional information.
  4. Click Save.

Once the study is created, assign your study team:

  1. Navigate to the Studies tab and select the applicable study.
  2. Open Study Team Assignments.
  3. Click +Assign.
  4. Select all staff that are on the study, assign a role, and click Next.
  5. Confirm assignments are accurate, and click Save.
  6. IMPORTANT: Change the state from Proposed to Active for each staff member. Users with the Site Staff system role will only be able to view study documents if they are assigned to the study in the Active state.

Need Help? Contact support at

3. Upload Study Documents

When adding a document, you will be prompted to enter information about its content. This generates the document name and determines where it is filed in the Study eBinder.

To upload regulatory documents:

  1. Navigate to Documents > Study eBinder and select the applicable study.
  2. Click Upload and select up to 20 files to upload or drag and drop documents directly into the eBinder.
  3. Choose the Document Type from the dropdown. View the Document Types Reference Spreadsheet to determine which document type to select.
  4. Select the upload state and any additional actions.
    • Select Upload as Approved for Use/Current/Final if the document is complete and no further processing is needed.
    • Select Upload as Draft if the document requires additional processing such as eSignature.
  5. Complete the required fields highlighted in yellow. Organizations and Products can be created directly from the document uploader.
  6. Click Save.

To move draft documents to the approved state, use the All Actions menu (…) next to the document in the eBinder or in the top right when viewing the document. For more information on using workflows such as eSignature and Read and Understand, visit the Help Center.

To upload source documents:

  1. Navigate to the Documents > Study eBinder tab.
  2. Expand the Upload dropdown menu to select Bulk Upload Source Docs.
  3. Select up to 100 source documents to upload from your computer.
  4. Complete the required fields and any optional fields as needed. Use the header row to quickly apply the same content to all fields.
  5. Click Save.

Need Help? Contact support at

Uploading Documents to the Study eBinder


Uploading Source Documents

Add Your Monitor to SiteVault

Adding your monitor enables them to review documents directly in SiteVault and provide real-time feedback electronically. Monitors can only view documents in the approved state (e.g. Approved for Use, Current, or Final).

  1. Navigate to Administration > Monitor & External Users and select Create.
  2. Enter your monitor’s email and click Check Email. Select the existing username if one is found, otherwise enter the required information to create a new account.
  3. Click Next to move to the Site Access and Study Assignment tab.
  4. Click +Add Study and select the applicable study. Optional: Schedule start and end access dates.
  5. Click Save.

Let your monitor know you have added them to SiteVault and send them the following link to show them how to review study documents: Completing Monitoring Visits as an External User.

Need Help? Contact support at

Granting Monitor/External User Access

Resolve Monitor Review Feedback

You’ll receive an email notification from SiteVault if a monitor has left feedback on a document. You can open the task by selecting the link in the email. Alternatively, you can find open tasks in the following places:

  • Navigate to the All Tasks view of the Home tab. Any monitor review tasks that are assigned to you are displayed as Address Review Feedback tasks.
  • Navigate to the Documents > Library tab and select the Open Monitor Feedback view.

To resolve monitor review feedback:

  1. Open the document, and select Accept on the task.
  2. If applicable, select View Annotations to view and respond to any annotations left by the monitor. Optionally, you can tag the monitor in your reply by typing @, entering a few letters of the monitor’s name, then selecting the monitor from the list.
  3. If applicable, select the Show more link on the task to view any instructions left by the monitor.
  4. When finished, select Complete on the task and select one of the following options in the dialog box:
    • Feedback Will Be Resolved Without Updating This Document: Select this option if you want to resolve the feedback without updating the document. The monitor is notified that the document is ready for another review.
    • New Document Version Will Be Created: Select this option if you want to update the document with a new version. Complete the steps below to create a new version of the document. Ensure that you finalize or approve the document to make it available for another review.

To create a new document version:

  1. Open the document and select Create Draft from the All Actions menu (…).
  2. Upload the new version, or copy and reuse the current source file.
  3. Click Create. SiteVault stacks a new version of the document on the original document.
  4. Use the All Actions menu (…) to move the new document version to the approved state to make it available for another review.

After the monitor review process is complete, you can delete any remaining annotations by selecting Delete Annotations from the Workflow Actions menu of the document.

To prepare for your next monitoring visit, view the Monitoring Visit Prep dashboard from the Reporting > Dashboards tab.

Need Help? Contact support at

Resolving Monitor Feedback


Deleting Annotations

Additional Resources

SiteVault 101: The Basics

Learn the basics of SiteVault in this 10 minute, self-paced video tutorial.

Access Tutorial
YouTube Videos

Watch bite-sized tutorials on the SiteVault YouTube channel.

Watch Videos
Help Center

Find comprehensive, self-service resources to learn more about SiteVault.

Visit the Help Center
Compliance Documentation

View SiteVault 21 CFR 11, Annex 11, and GDPR compliance documentation.

Audit and Inspection Tools


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